U.S. patent number 9,700,320 [Application Number 14/474,899] was granted by the patent office on 2017-07-11 for devices and methods for removably coupling a cartridge to an end effector of a surgical device.
This patent grant is currently assigned to Ethicon LLC. The grantee listed for this patent is Ethicon LLC. Invention is credited to Brian F. Dinardo, John S. Kimsey, Jerome R. Morgan, Mark D. Overmyer, Sol A. Posada, Frederick E. Shelton, IV.
United States Patent |
9,700,320 |
Dinardo , et al. |
July 11, 2017 |
Devices and methods for removably coupling a cartridge to an end
effector of a surgical device
Abstract
Devices and methods are provided for removably coupling a
cartridge to an end effector of a surgical device. In general, one
of a cartridge and a surgical device can include at least one
mating element, and the other of the cartridge and the surgical
device can include at least one engagement feature configured to
removably engage the at least one mating element. The engagement of
the at least one mating element and the at least one engagement
feature can help ensure that the cartridge is fully mated to the
surgical device such that the surgical device can properly fire
fasteners disposed within the cartridge. The engagement of the at
least one mating element and the at least one engagement feature
can be configured to provide a positive indication that the
cartridge is fully seated in an end effector of the surgical
device.
Inventors: |
Dinardo; Brian F. (Cincinnati,
OH), Overmyer; Mark D. (Cincinnati, OH), Kimsey; John
S. (Florence, KY), Posada; Sol A. (Cincinnati, OH),
Shelton, IV; Frederick E. (Hillsboro, OH), Morgan; Jerome
R. (Cincinnati, OH) |
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon LLC |
Guaynabo |
PR |
US |
|
|
Assignee: |
Ethicon LLC (Guaynabo,
PR)
|
Family
ID: |
54014742 |
Appl.
No.: |
14/474,899 |
Filed: |
September 2, 2014 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20160058440 A1 |
Mar 3, 2016 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/07207 (20130101); A61B 2017/00862 (20130101); A61B
2017/2936 (20130101); A61B 2090/033 (20160201); A61B
2017/07271 (20130101); A61B 2090/037 (20160201); A61B
2090/0808 (20160201); A61B 2017/0725 (20130101); A61B
2017/3492 (20130101); A61B 2017/00477 (20130101); A61B
2017/347 (20130101); A61B 17/3423 (20130101) |
Current International
Class: |
A61B
17/02 (20060101); A61B 17/10 (20060101); A61B
17/072 (20060101); A61B 17/29 (20060101); A61B
17/00 (20060101); A61B 17/34 (20060101); A61B
90/00 (20160101) |
Field of
Search: |
;227/175.1-182.1
;606/139,219 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"MicroCutter XCHANGE.TM. 30." Inservice Poster. (Oct. 13). cited by
applicant .
"MicroCutter XCHANGE.TM. 30." Instructions for Use. (2014). cited
by applicant .
"MicroCutter XCHANGE.TM. 30 Videos." Cardica. Web. May 7, 2014.
http://www.cardica.com/inservice-guide.php. cited by applicant
.
"MicroCutter XCHANGE.TM. 30: The World's First and Only
Articulating 5mm Stapler." Cardica. Web. May 7, 2014.
http://www.cardica.com/minimally-invasive-surgery.php. cited by
applicant .
U.S. Appl. No. 14/300,954, filed Jun. 10, 2014. cited by
applicant.
|
Primary Examiner: Long; Robert
Claims
What is claimed is:
1. A surgical fastening device, comprising: an elongate shaft; an
end effector coupled to a distal end of the elongate shaft, the end
effector including a cartridge jaw and an anvil pivotally coupled
to one another and configured to engage tissue therebetween; a
staple cartridge configured to be removably disposed within a
channel formed in the cartridge jaw, the staple cartridge including
a plurality of staples disposed therein; and a latch formed on one
of the cartridge jaw and the staple cartridge, the latch being
configured to extend into a corresponding engagement feature formed
in the other one of the cartridge jaw and the staple cartridge when
the staple cartridge is fully seated within the cartridge jaw,
wherein the latch protrudes radially outward beyond an outer
diameter of the elongate shaft and end effector when the latch is
not engaged with the corresponding engagement feature; wherein the
plurality of staples in the cartridge are configured to rotate
about a pivot point into tissue engaged between the cartridge jaw
and the anvil.
2. The device of claim 1, wherein the latch is formed on a proximal
portion of the cartridge jaw, and the corresponding engagement
feature is formed on the staple cartridge.
3. The device of claim 1, wherein the corresponding engagement
feature comprises a cut-out.
4. The device of claim 1, wherein the latch comprises a deflectable
spring-arm configured to snap into the corresponding engagement
feature when the staple cartridge is fully seated in the cartridge
jaw.
5. The device of claim 1, wherein the plurality of staples are each
frangibly coupled to a carrier.
6. A surgical fastening device, comprising: an elongate shaft; an
end effector coupled to a distal end of the elongate shaft, the end
effector including a cartridge jaw and an anvil pivotally coupled
to one another and configured to engage tissue therebetween; a
staple cartridge configured to be removably disposed within a
channel formed in the cartridge jaw, the staple cartridge including
a plurality of staples disposed therein; a mating element formed on
one of the staple cartridge and the cartridge jaw and configured to
engage a corresponding engagement feature in the other one of the
staple cartridge and the cartridge jaw when the staple cartridge is
fully seated within the cartridge jaw; and at least one biasing
element disposed within a channel formed in the cartridge jaw, the
at least one biasing element being configured to bias the staple
cartridge out of the channel in the cartridge jaw when the mating
element is not engaged with the engagement feature; wherein the
plurality of staples in the cartridge are configured to rotate
about a pivot point into tissue engaged between the cartridge jaw
and the anvil.
7. The device of claim 6, wherein the mating element comprises a
deflectable spring arm formed on the staple cartridge, and wherein
the corresponding engagement feature comprises a cut-out formed in
the cartridge jaw.
8. The device of claim 6, wherein the mating element comprises
first and second deflectable spring arms formed on opposed lateral
sides of the staple cartridge, and wherein the corresponding
engagement feature comprises first and second cut-outs formed in
opposed lateral sides of the cartridge jaw.
9. The device of claim 6, wherein the biasing element comprises at
least one spring.
10. The device of claim 9, wherein the at least one spring is
compressed when the staple cartridge is fully seated in the
cartridge jaw.
11. The device of claim 6, wherein the biasing element is formed
within a proximal portion of the channel in the cartridge jaw.
Description
FIELD OF THE INVENTION
The present disclosure relates generally to removably coupling a
cartridge to an end effector of a surgical device.
BACKGROUND
Minimally invasive surgical instruments are often preferred over
traditional open surgical devices due to the reduced post-operative
recovery time and minimal scarring associated with minimally
invasive procedures. Laparoscopic surgery is one type of minimally
invasive surgery (MIS) procedure in which one or more small
incisions are formed in the abdomen and a trocar is inserted
through the incision to form a pathway that provides access to the
abdominal cavity. The trocar is used to introduce various
instruments and tools into the abdominal cavity, as well as to
provide insufflation to elevate the abdominal wall above the
organs. Endoscopic surgery is another type of MIS procedure in
which elongate flexible shafts are introduced into the body through
a natural orifice.
Due to the benefits associated with minimally invasive surgeries,
significant efforts have gone into developing a range of endoscopic
and laparoscopic surgical instruments that are suitable for precise
placement of a distal end effector at a desired surgical site.
These distal end effectors engage the tissue in a number of ways to
achieve a diagnostic or therapeutic effect (e.g., grasper, cutter,
stapler, clip applier, access device, drug/gene therapy delivery
device, and energy device using ultrasound, radiofrequency, laser,
etc.).
For example, staplers including end effectors for grasping tissue
have been developed which secure tissue between two jaws. Staples
contained in one of the jaws can be driven into the grasped tissue
and deformed to hold the tissue by impinging on the other jaw. The
staples can form a predetermined pattern (e.g., one or more lines
of staples) based upon the configuration of the staples in the one
of the jaws. The stapler can be a linear stapler, in which the
predetermined pattern includes one or more longitudinal lines of
staples. Though staplers can be effective to grasp and staple
tissue, it can be difficult to grasp and/or staple the tissue based
on a variety of factors, such as a size and/or shape of the staple,
a thickness and/or toughness of the tissue, etc.
Some staplers can be refilled after firing staples. In some
staplers, the staples can be contained in a cartridge which can be
removable from the stapler's jaw to allow the stapler to be
refilled with staples contained in another cartridge inserted into
the jaw. However, this refilling of cartridges can be difficult
since the cartridges can be relatively small and accordingly
difficult to manipulate and/or properly secure within the jaw.
Refilling a stapler with a new cartridge can thus be time consuming
and/or can result in an improperly loaded cartridge that can
misfire staples or otherwise function improperly during use on a
patient.
Accordingly, there remains a need for improved methods and devices
for stapling tissue.
SUMMARY
A surgical fastening device comprises an elongate shaft and an end
effector coupled to a distal end of the elongate shaft such that
the end effector includes a cartridge jaw and an anvil pivotally
coupled to one another and configured to engage tissue
therebetween. The device also includes a staple cartridge
configured to be removably disposed within a channel formed in the
cartridge jaw, wherein the staple cartridge includes a plurality of
staples disposed therein. The device further includes a latch
formed on one of the cartridge jaw and the staple cartridge,
wherein the latch is configured to extend into a corresponding
engagement feature formed in the other one of the cartridge jaw and
the staple cartridge when the staple cartridge is fully seated
within the cartridge jaw. The latch can protrude radially outward
beyond an outer diameter of the elongate shaft and end effector
when the latch is not engaged with the corresponding engagement
feature.
In one aspect the latch is formed on a proximal portion of the
cartridge jaw and the corresponding engagement feature is formed on
the staple cartridge. The corresponding engagement feature can
comprise a cut-out. In one aspect the latch comprises a deflectable
spring-arm configured to snap into the corresponding engagement
feature when the staple cartridge is fully seated in the cartridge
jaw.
The device is constructed such that the plurality of staples in the
cartridge are configured to rotate about a pivot point into tissue
engaged between the cartridge jaw and the anvil. Further, the
plurality of staples are each frangibly coupled to a carrier.
In another aspect a surgical fastening device comprises an elongate
shaft and an end effector coupled to a distal end of the elongate
shaft such that the end effector includes a cartridge jaw and an
anvil pivotally coupled to one another and configured to engage
tissue therebetween. The device also includes a staple cartridge
configured to be removably disposed within a channel formed in the
cartridge jaw, wherein the staple cartridge including a plurality
of staples disposed therein. The device further includes a mating
element formed on one of the staple cartridge and the cartridge jaw
and configured to engage a corresponding engagement feature in the
other one of the staple cartridge and the cartridge jaw when the
staple cartridge is fully seated within the cartridge jaw. Finally,
the device includes at least one biasing element disposed within a
channel formed in the cartridge jaw, wherein the at least one
biasing element is configured to bias the staple cartridge out of
the channel in the cartridge jaw when the mating element is not
engaged with the engagement feature.
The mating element can comprise a deflectable spring arm formed on
the staple cartridge, and wherein the corresponding engagement
feature comprises a cut-out formed in the cartridge jaw.
Alternatively, the mating element comprises first and second
deflectable spring arms formed on opposed lateral sides of the
staple cartridge, and wherein the corresponding engagement feature
comprises first and second cut-outs formed in opposed lateral sides
of the cartridge jaw. In one aspect the biasing element comprises
at least one spring. The at least one spring can be compressed when
the staple cartridge is fully seated in the cartridge jaw. In one
aspect the biasing element is formed within a proximal portion of
the channel in the cartridge jaw.
A method for attaching a staple cartridge to an end effector of a
stapling device is also provided. The method comprises positioning
a staple cartridge in a channel formed within a cartridge jaw of an
end effector of a surgical stapling device, the cartridge jaw
having an anvil pivotally coupled thereto, wherein a mating feature
on one of the staple cartridge and the cartridge jaw snaps into a
corresponding engagement feature on the other one of the staple
cartridge and the cartridge jaw, and wherein a biasing element on
the end effector and separate from the mating feature results in a
positive indication to a user when the staple cartridge is not
fully seated within the cartridge jaw. The method can further
comprise inserting the end effector through a trocar extending
through a tissue wall and into a body cavity of a patient, the
deflectable spring arm preventing insertion of the end effector
into the body cavity when the staple cartridge is not fully seated
within the cartridge jaw.
BRIEF DESCRIPTION OF THE DRAWINGS
This invention will be more fully understood from the following
detailed description taken in conjunction with the accompanying
drawings, in which:
FIG. 1 is a perspective view of one embodiment of a surgical device
configured to apply fasteners to tissue and including an end
effector, the end effector being in a closed position;
FIG. 2 is a perspective view of the end effector of FIG. 1 in an
open position;
FIG. 3 is a perspective view of the end effector of FIG. 2 with one
embodiment of a cartridge removably coupled thereto;
FIG. 4 is a perspective, partially cross-sectional view of the end
effector and the cartridge of FIG. 3;
FIG. 5 is a perspective view of the cartridge of FIG. 3;
FIG. 6 is another perspective view of the cartridge of FIG. 3;
FIG. 7 is a perspective view of a sled of the cartridge of FIG. 3,
the sled including a cutting element, and the cutting element being
in a first position;
FIG. 8 is a perspective view of the sled of FIG. 7 with the cutting
element in a second position that is different from the first
position;
FIG. 9 is a side partially cross-sectional view of one embodiment
of a distal portion of a surgical device configured to removably
seat a cartridge in an end effector thereof, the cartridge being
fully seated in the end effector;
FIG. 10 is a side partially transparent view of the distal portion
of the surgical device of FIG. 9, the cartridge not being seated in
the end effector;
FIG. 11 is a side cross-sectional view of a portion of the surgical
device of FIG. 9;
FIG. 12 is a side cross-sectional view of a portion of the surgical
device of FIG. 10;
FIG. 13 is a perspective view of the distal portion of the surgical
device of FIG. 10 with the end effector partially inserted into one
embodiment of a trocar;
FIG. 14 is a perspective exploded view of another embodiment of a
distal portion of a surgical device configured to removably seat a
cartridge in an end effector thereof;
FIG. 15 is a top cross-sectional view of the cartridge of FIG. 14
fully seated in the end effector;
FIG. 16 is a top cross-sectional view of the cartridge of FIG. 14
not fully seated in the end effector;
FIG. 17 is a side cross-sectional view of another embodiment of a
distal portion of a surgical device configured to removably seat a
cartridge in an end effector thereof, the cartridge being fully
seated in the end effector; and
FIG. 18 is a perspective exploded, partially cross-sectional view
of one embodiment of a distal portion of a surgical device
including an elongate shaft and an end effector configured to
removably couple to the elongate shaft.
DETAILED DESCRIPTION
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those skilled in the art will understand
that the devices and methods specifically described herein and
illustrated in the accompanying drawings are non-limiting exemplary
embodiments and that the scope of the present invention is defined
solely by the claims. The features illustrated or described in
connection with one exemplary embodiment may be combined with the
features of other embodiments. Such modifications and variations
are intended to be included within the scope of the present
invention.
Further, in the present disclosure, like-named components of the
embodiments generally have similar features, and thus within a
particular embodiment each feature of each like-named component is
not necessarily fully elaborated upon. Additionally, to the extent
that linear or circular dimensions are used in the description of
the disclosed systems, devices, and methods, such dimensions are
not intended to limit the types of shapes that can be used in
conjunction with such systems, devices, and methods. A person
skilled in the art will recognize that an equivalent to such linear
and circular dimensions can easily be determined for any geometric
shape. Sizes and shapes of the systems and devices, and the
components thereof, can depend at least on the anatomy of the
subject in which the systems and devices will be used, the size and
shape of components with which the systems and devices will be
used, and the methods and procedures in which the systems and
devices will be used.
It will be appreciated that the terms "proximal" and "distal" are
used herein with reference to a user, such as a clinician, gripping
a handle of an instrument. Other spatial terms such as "front" and
"back" similarly correspond respectively to distal and proximal. It
will be further appreciated that for convenience and clarity,
spatial terms such as "vertical" and "horizontal" are used herein
with respect to the drawings. However, surgical instruments are
used in many orientations and positions, and these spatial terms
are not intended to be limiting and absolute.
FIG. 1 illustrates one embodiment of a surgical device 1100 that
can be configured to apply staples to tissue. The device 1100 in
this illustrated embodiment includes a linear stapler configured to
apply linear rows of staples. Other embodiments of surgical devices
that can be configured to apply staples to tissue are described in
U.S. Pat. No. 5,465,895 entitled "Surgical Stapler Instrument"
filed Feb. 3, 1994, U.S. Pat. No. 7,000,818 entitled "Surgical
Stapling Instrument Having Separate Distinct Closing And Firing
Systems" filed May 20, 2003, U.S. Pat. No. 7,669,746 entitled
"Staple Cartridges For Forming Staples Having Differing Formed
Staple Heights" filed on Aug. 31, 2005, and U.S. Pat. Pub. No.
2014/0175146 entitled "Microcutter Stapling Apparatus Clamp And
Deploy Mechanisms Systems And Methods" filed Dec. 19, 2013, which
are hereby incorporated by reference in their entireties.
Referring again to FIG. 1, the device 1100 can include a proximal
handle portion 1102 having an elongate shaft 1104 extending
distally therefrom. As also shown in FIG. 2 and FIG. 3, the shaft
1104 can have an end effector 1106 coupled to a distal end thereof.
The end effector 1106 can be coupled to the shaft 1104 at a pivot
joint 1108. A proximal end of the end effector 1106 can be
pivotally coupled to the joint 1108 at a distal end of the shaft
1104. The end effector 1106 in this illustrated embodiment includes
a tissue grasper having a pair of opposed first and second jaws
1110a, 1110b configured to move between open and closed positions.
The first jaw is also referred to herein as a "bottom jaw" and a
"cartridge jaw," and the second jaw is also referred to herein as
an "upper jaw" and an "anvil." As discussed further below, the
handle portion 1102 can be configured to be manipulated to effect
the opening and closing of the opposed jaws 1110a, 1110b, e.g.,
movement of one or both the jaws 1110a, 1110b about the pivot joint
1108, and the handle portion 1102 can be configured to be
manipulated to effect the firing of staples (not shown) from a one
of the jaws 1110a, 1110b, e.g., a bottom or cartridge one of the
jaws 1110a. The staple firing can be independent of the opening and
closing of the jaws 1110a, 1110b.
The handle portion 1102 can have a variety of sizes, shapes, and
configurations. The handle portion 1102 can include a main housing
1121, which can house a variety of elements therein and can have
some elements accessible outside thereof, such as a movable trigger
1122 and a stationary handle 1124. The movable trigger 1122 can be
configured to be manually manipulated to move the movable trigger
1122 relative to the stationary handle 1124 so as to, e.g., effect
closing of the jaws 1110a, 1110b.
The shaft 1104 can have a variety of sizes, shapes, and
configurations. In an exemplary embodiment, the shaft 1104 can be
rigid, e.g., made from a generally non-bendable material such as a
metal (e.g., stainless steel, titanium, etc.) or a hard polymer. In
other embodiments, the shaft 1104 can be configured to bend, such
as being made from a generally flexible material, by including one
or more articulation regions, etc. The shaft 1104 can have any
longitudinal length, although in an exemplary embodiment it can be
long enough to allow the handle portion 1102 to be manipulated
outside a patient's body while the shaft 1104 extends through an
opening in the body with the end effector 1106 disposed within a
body cavity. In this way, the end effector 1106 can be easily
manipulated when the device 1100 is in use during a surgical
procedure. The shaft 1104 can have any diameter. For example, the
shaft's diameter can be less than or equal to about 10 mm, e.g.,
less than or equal to about 7 mm, less than or equal to about 5 mm,
etc., which can allow for insertion of the shaft 1104 through an
minimally invasive access device, e.g., a trocar, a cannula, a
multiport access device, etc., such as during a laparoscopic
surgical procedure. The end effector 1106 coupled to the shaft's
distal end can have a diameter equal to or less than the shaft's
diameter, at least when the jaws 1110a, 1110b are in the closed
position, which can facilitate insertion of the device's distal
portion into a patient's body.
The end effector 1106 can have a variety of sizes, shapes, and
configurations. In an exemplary embodiment, the end effector 1106
can be rigid. As shown in FIG. 2 and FIG. 3, the end effector 1106
including the first and second jaws 1110a, 1110b can be disposed at
a distal end of the surgical device 1100. As in this illustrated
embodiment, when the jaws 1110a, 1110b move between the open and
closed positions, the second jaw 1110b can be configured to remain
stationary relative to the shaft 1104, and the first jaw 1110a can
be configured to move relative to the shaft 1104 and the second jaw
1110b by pivoting at the pivot joint 1108.
The end effector 1106 can be configured to releasably and
replaceably seat a cartridge 1112 therein, as shown in FIG. 3 and
FIG. 4. In this way, when the staples have been fired from the
cartridge 1112, the cartridge 1112 can be removed from the second
jaw 1110b and, optionally, replaced with another cartridge having
another plurality of staples disposed therein. FIG. 2 shows the end
effector 1106 without the cartridge 1112 seated therein. The end
effector 1106 can be configured to receive the cartridge 1112 in
the first jaw 1110a thereof, e.g., in a channel formed in the first
jaw 1110a. The first jaw 1110a can be configured to seat cartridges
of different sizes, thereby facilitating versatility of the device
1100.
The cartridge 1112 can have a variety of sizes, shapes, and
configurations, as will be appreciated by a person skilled in the
art. As shown in FIG. 4, FIG. 5, and FIG. 6, the cartridge 1112 can
include a sled 1120 and can have a plurality of staples 1116
disposed therein. The sled 1120 is also illustrated in FIG. 7 and
FIG. 8. The cartridge 1112 can include a plurality openings 1114
formed in a tissue engaging surface 1118 thereof, as shown in FIG.
3, FIG. 5, and FIG. 6. The staples 1116 disposed in the cartridge
1112 can be configured to be ejected from the cartridge 1112
through the openings 1114, e.g., one staple 1116 out of each
opening 1114 (as in this illustrated embodiment), two staples out
of each opening 1114, etc. The openings 1114 can define
staple-receiving recesses of the cartridge 1112 in which the
staples 1116 are seated prior to being ejected from the cartridge
1112.
The staples 1116 can have a variety of sizes, shapes, and
configurations. In this illustrated embodiment, the staples 1116
each have a D-shape and include a first leg that is substantially
straight and a second leg that is curved. A person skilled in the
art will appreciate that the first leg may not be precisely
straight, e.g., due to manufacturing tolerances, but nevertheless
be considered to be substantially straight. Each of the staples
1116 can be configured to be plastically deformable such that the
staples 1116 can each be configured to change shape, such as when
the staple 1116 is pressed against a tissue engaging surface (not
shown) of the first jaw 1110a that faces the tissue engaging
surface 1118 of the second jaw 1110b, while remaining a single
unit, e.g., without either of the first and second legs breaking. A
gap of space can exist between a terminal end of the first leg and
a terminal end of the second leg. In other words, the "D" shape can
have a gap therein. The gap of space can facilitate plastic
deformation of the staple 1116.
The staples 1116 can each be frangibly attached to a carrier 1126,
also referred to herein as a "carrier strip," disposed within the
cartridge 1112. The staples 1116 can be frangibly attached to the
carrier 1126 by, e.g., being stamped together with the carrier 1126
such that the staples 1116 and the carrier 1126 forms a single
piece. The staples 1116 can each be configured to detach from the
carrier 1126 when fired from the cartridge 1112. In some
embodiments, some or all of the staples 1116 can be frangibly
attached to another element, such as another element disposed
within the cartridge 1112, an inner surface of the cartridge 1112,
the tissue-engaging surface 1118 of the cartridge 1112, etc. The
carrier 1126 can be fixedly attached to an upper surface of one or
more rails 1128 defined by the cartridge 1112. The carrier 1126 can
be configured to remain stationary relative to the cartridge
1112.
As shown in FIG. 3, FIG. 5, and FIG. 6, the cartridge 1112 can have
a longitudinal slot 1130 formed therein. The longitudinal slot 1130
can extend along a substantially flat central portion 1118f of the
tissue-engaging surface 1118. The slot 1130 can be configured to
have a cutting element such as a knife (not shown) extend
therethrough so as to be configured to cut tissue engaged by the
tissue-engaging surface 1118, as discussed further below. The
openings 1114 can be formed in angled portions 1118a of the
tissue-engaging surface 1118 on both sides of the slot 1130, as
shown in FIG. 3, FIG. 5, and FIG. 6. In some embodiments, the
tissue-engaging surface 1118 can be substantially flat, e.g., not
have angled portions, while in other embodiments, the
tissue-engaging surface 1118 can be angled, e.g., not have any
substantially flat portions.
As shown in FIG. 5 and FIG. 6, the cartridge 1112 can include a
gap-setting feature 1142 configured to set of gap of space between
the first and second jaws 1110a, 1110b when the jaws 1110a, 1110b
are closed and the cartridge 1112 is seated in the second jaw
1110b. In this way, the gap-setting feature 1142 can be configured
to define a minimum distance between the facing tissue-engaging
surfaces of the first and second jaws 1110a, 1110b. The gap-setting
feature 1142 can have a variety of sizes, shapes, and
configurations. As in this illustrated embodiment, the gap-setting
feature 1142 can include an indentation inward toward a lateral
center of the cartridge 1112, where a portion of a lateral edge of
the cartridge 1112 immediately proximal to the gap-setting feature
1142 is located laterally inward relative to a portion of a lateral
edge of the cartridge 1112 located immediately distal to the
gap-setting feature 1142.
The sled 1120 of the cartridge 1112 can have a variety of sizes,
shapes, and configurations. The sled 1120 can be configured to
translate longitudinally along the cartridge 1112 to cause
deployment of the staples 1116 therefrom and to cause tissue
engaged by the end effector 1106 to be cut with the cutting element
extending through the slot 1130. The staples 1116 can be arranged
longitudinally in the cartridge 1112, as shown in FIG. 4, and the
sled 1120 can be configured to sequentially engage the
longitudinally arranged staples 1116 as the sled 1120 translates
longitudinally. As illustrated in FIG. 7 and FIG. 8, the sled 1120
can include a plurality of wedges 1136 and can include a cutting
element 1134, which in this illustrated embodiment includes a knife
with a blade 1132. The sled 1120 in this illustrated embodiment
includes four wedges 1136 but the sled 1120 can include another
number of wedges 1136 as appropriate for the arrangement of the
staples 1116 in the cartridge 1112. Each of the wedges 1136 can
have a shape configured to cause the staples 1116 contacted by that
wedge 1136 to move upward toward the second jaw 1110b through the
openings 1114 and deform against the second jaw 1110b. As shown in
FIG. 6, the cartridge 1112 can include a plurality of longitudinal
slots 1150 formed therein, each of the slots 1150 being configured
to slidably receive one of the wedges 1136 therein. The slots 1150
can facilitate consistent, straight movement of the wedges 1136
through the cartridge 1112 to help ensure proper engagement of the
wedges 1136 with the staples 1116.
Each of the wedges 1136 can be attached to a base 1138 of the sled
1120 and can be in a fixed position relative thereto. The base 1138
can have a guide element 1139 extending generally downward
therefrom. The guide element 1139 can be configured to slide within
a channel formed in the cartridge 1112 that includes the sled 1120.
The cutting element 1134 can also be attached to the base 1138, but
the cutting element 1134 can be configured to move relative to the
base 1138. The cutting element 1134 can be substantially laterally
centered in the base 1138, which can facilitate substantially
central positioning of the cutting element 1134 relative to tissue
engaged by the end effector 1106.
The cutting element 1134 can be configured to be movable relative
to a remainder of the sled 1120 between a first position, shown in
FIG. 7, and a second position, shown in FIG. 6 and FIG. 8. The
first position can be an initial position of the cutting element
1134. In the first position, also referred to herein as a "stowed
position," the blade 1132 can be generally obscured, e.g., oriented
generally downward as shown in the embodiment of FIG. 4, FIG. 5,
FIG. 6, and FIG. 7, which can help prevent the blade 1132 from
inadvertent cutting, such as accidentally cutting a user of the
device 1100 during seating of the cartridge 1120 within the end
effector 1104 and/or premature cutting of tissue engaged by the end
effector 1104. The base 1138 can have a cavity 1144 formed therein,
as shown in FIG. 6, which can be configured to seat the cutting
element 1134 at least partially therein when the cutting element
1134 is in the first position. In the second position, also
referred to herein as an "upright position," the blade 1132 can be
generally unobscured and facing a distal direction as shown in the
embodiment of FIG. 6 and FIG. 8, which can allow the blade 1132 to
extend through the slot 1130 and cut tissue engaged by the end
effector 1106.
The sled 1120 can include a pivot member 1140 configured to
facilitate movement of the cutting element 1134 relative to the
remainder of the sled 1120. The pivot member 1140 can have a
variety of sizes, shapes, and configurations. The pivot member 1140
can be attached to the cutting element 1134 such that engagement of
the pivot member 1140 can cause the cutting element 1134 to pivot
about a pivot point so as to move relative to the remainder of the
sled. As in this illustrated embodiment the pivot member 1140 can
include two separate pins extending laterally from opposite sides
of the cutting element 1134. In other embodiments, the pivot member
1140 can include a single pin extending through the cutting element
1134 to extend laterally from opposite sides therefrom, a single
pin extending laterally from one side of the cutting element 1134,
etc. At the pivot point, the sled 1120 can include a pivot axle
1146 extending laterally from the cutting element 1134, and can
include an axle cavity 1148 formed in the base 1138 and configured
to receive the pivot axle 1146 therein.
The surgical devices described herein can be used in a variety of
surgical procedures. In an exemplary embodiment, the procedure can
be a minimally invasive procedure in which the surgical device can
be advanced into a body of a patient through a relatively small
opening in the patient. In a minimally invasive surgical procedure,
one or more introducer devices (not shown), e.g., a cannula, a
trocar, etc., can be advanced through an opening in the patient to
provide access to a surgical site. A person skilled in the art will
appreciate that one or more viewing devices, e.g., a scoping device
such as an endoscope, can be advanced into the body through the
incision or through another opening, e.g., another incision or a
natural orifice, to provide visualization of the surgical site from
outside the body. As will be appreciated by a person skilled in the
art, the surgical device can be advanced into the patient's body in
a variety of ways, such as by being inserted transorally therein,
inserted through an introducer device, inserted through a scoping
device, inserted directly through an incision, etc. Although the
following embodiment of use of a surgical device in a surgical
procedure is described with respect to the device 1100 of FIG. 1,
any of the surgical devices described herein can be similarly
used.
The surgical devices described herein can have any one or more
variations to facilitate effective use of the device. Examples of
such variations are described further below.
In some embodiments, a surgical device such as the above-mentioned
surgical device 1100 can be configured to facilitate removable
coupling of a cartridge to an end effector of a surgical device. In
general, one of the cartridge and the surgical device can include
at least one mating element, and the other of the cartridge and the
surgical device can include at least one engagement feature
configured to removably engage the at least one mating element. The
engagement of the at least one mating element and the at least one
engagement feature can help ensure that the cartridge is fully
mated to the surgical device such that the surgical device can
properly fire fasteners disposed within the cartridge. Some
embodiments of surgical devices can be configured to prevent
fastener firing unless the cartridge is fully seated therein. The
engagement of the at least one mating element and the at least one
engagement feature can be configured to provide a positive
indication that the cartridge is fully seated in the end effector.
The positive indication can be visually and/or audibly detectable
by a user seating the cartridge in the surgical device's end
effector, thereby allowing the user to verify proper seating of the
cartridge. The visual detection of the at least one mating element
and the at least one engagement feature's engagement can be from an
outside of the device such that no further assembly or disassembly
of the device is needed to perform the visual detection and/or such
that no special tools, e.g., a magnifier, are needed for the visual
detection.
Some end effectors have particularly small diameters, such as those
appropriate for use in a minimally invasive surgical procedure,
such that cartridges removably disposable therein are
correspondingly small. It can be difficult to handle these small
cartridges and to ensure that they are fully seated within these
small end effectors. The surgical device and the cartridge
including the at least one mating element and the at least one
engagement feature can facilitate removable disposal of the
cartridge within the end effector, even when the cartridge and the
end effector have particularly small diameters.
A surgical device can be configured to facilitate removable
coupling of a cartridge to a surgical device's end effector in a
variety of ways. In the embodiments described below, staples are
used as examples of fasteners, but as will be appreciated by a
person skilled in the art, other types of fasteners can be
similarly configured and used.
In some embodiments, a mating element can be in the form of a
latch. FIG. 9, FIG. 10, FIG. 11, and FIG. 12 illustrate one
embodiment of a mating element 6014 that includes a latch. In
general, the mating element 6014 can be configured to removably
couple to an engagement feature 6016, thereby facilitating
removable seating of a cartridge 6008 within an end effector 6004
of a surgical device 6000. The end effector 6004 can be coupled to
a distal end of the device's elongate shaft 6002, and can include
an upper jaw 6020 and a bottom jaw 6008. As discussed herein, one
of the jaws 6020, 6018 can include a channel (not shown) formed
therein that can be configured to removably seat the cartridge 6008
therein. In this illustrated embodiment, the bottom jaw 6018
includes the channel configured to releasably and replaceably seat
the cartridge 6008.
As in this illustrated embodiment, the surgical device 6000 can
include the mating element 6014, and the cartridge 6008 can include
the engagement feature 6016. The mating element 6014 can be formed
on a distal portion of the device 6000 adjacent the end effector
6004, and the engagement feature 6016 can be formed on a proximal
portion of the cartridge 6008, as in this illustrated embodiment.
In other embodiments, as mentioned above, on the cartridge 6008 can
include the mating element 6014, e.g., in a proximal portion
thereof, and the surgical device 6000 can include the engagement
feature 6016, e.g., in a distal portion thereof adjacent the end
effector 6004. There is only one mating element 6014 in this
illustrated embodiment and one engagement feature 6016, but one or
more mating elements 6014, e.g., two latches, and one or more
corresponding engagement features 6016 can be used.
The latch 6014 and the engagement feature 6016 can each have a
variety of sizes, shapes, and configurations. As in this illustrate
embodiment, the latch 6014 can include an arm having a first end
fixedly attached to the device 6000, e.g., to the shaft 6002. The
latch 6014 can also include a second, opposite end freely movable
relative to the device 6000, e.g., to the shaft 6002 and the end
effector 6004, when the latch 6014 is not fully mated with the
engagement feature. The second end can include a protrusion formed
thereon and extending radially inward. The latch 6014 can be
configured to dynamically move in response to insertion of the
cartridge 6008 into the bottom jaw 6018, thereby allowing the latch
6014 to automatically engage the engagement feature 6016 when the
cartridge 6008 is properly seated within the bottom jaw 6018, such
as by the latch 6014 snapping into the engagement feature 6016. In
some embodiments, this snapping can make an audibly detectable
noise, thereby indicating proper seating of the cartridge 6008
within the bottom jaw 6018. The latch 6014 can be configured to so
dynamically move by including a deflectable spring-arm, as in this
illustrated embodiment.
As in this illustrated embodiment, the engagement feature 6016 can
include a notch, also referred to herein as a "cut-out," configured
to receive the mating element 6014, e.g., the protrusion thereof,
therein. The engagement feature 6016 can have a size and shape
corresponding to a size and shape of the mating element 6014, e.g.,
the protrusion thereof, so as to facilitate a tight, secure fit of
the mating element 6014 within the engagement feature 6016.
In general, the latch 6014 can be configured to extend into the
engagement feature 6016 so as to be completely mated thereto. FIG.
9 and FIG. 11 show the mating element 6014 mated with the
engagement feature 6016, the cartridge 6008 thus being fully seated
within the bottom jaw 6018. The mating element 6014 being
completely mated with the engagement feature 6016 can be visually
detectable by looking at the device 6000, thereby indicating to a
user that the device 6000 can be used to fire fasteners (not shown)
from the cartridge 6008. The latch 6014 can be configured to
protrude radially outward beyond an outer diameter of the shaft
6002 when the latch 6014 is not engaged with, e.g., is misaligned
from, the engagement feature 6016. FIG. 10 and FIG. 12 show the
mating element 6014 unengaged with the engagement feature 6016,
thereby indicating that the cartridge 6008 is not fully seated
within the bottom jaw 6018. The mating element 6014 being
incompletely mated with the engagement feature 6016 can be visually
detectable by looking at the device 6000, thereby allowing a user
to readjust the cartridge 6008 so as to properly seat the cartridge
6008 in the end effector 6004. FIG. 10 also shows that the latch
6014 can extend a distance 6006 radially outward from the shaft's
6002 outer surface 6010 when the mating element 6014 and the
engagement feature 6016 are not engaged together.
The mating element 6014 can be configured to prevent the end
effector 6004 from being inserted into a patient, e.g., into a body
cavity thereof, when the mating element 6014 is not fully mated to
the engagement feature 6016. Thus, if a user does not realize that
the cartridge 6008 is not properly seated in the bottom jaw 6018 of
the end effector 6004 and tries to insert in the end effector 6004
into the patient, the mating element 6014 can indicate to the user
that the cartridge 6008 is not properly seated in the bottom jaw
6018 and should be readjusted thereto before inserting the end
effector 6004 into the patient for the device 6000 to properly
function within the patient, e.g., for the device 6000 to properly
fire fasteners therein.
As shown in one embodiment in FIG. 13, the mating element 6014 can
be configured to prevent the end effector 6004 from being inserted
into a patient's tissue 6012 to access a body cavity (not shown)
underneath the tissue by abutting an access device 6022 disposed
within the tissue 6012 through which the end effector 6004 is
attempting to be advanced. The access device 6022 includes a trocar
in this illustrated embodiment, but other types of access devices
can be similarly used, as will be appreciated by a person skilled
in the art. The access device 6022 can include a port 6024
extending therethrough through which the end effector 6004 can be
inserted. The port 6024 can have a diameter. The end effector 6004
can have a diameter corresponding to the port's diameter in the
closed position such that with the mating element 6014 extending
the distance 6006 radially outward, the end effector's 6004
diameter can be effectively increased. This increased diameter can
prevent the end effector 6004 from being advanced through the
access device 6022. For example, the port's diameter can be
configured to accommodate a device having a 5 mm diameter, and the
end effector 6004 can have a 5 mm diameter when the cartridge 6008
is fully seated in the bottom jaw 6018. When the cartridge 6008 is
not fully seated in the bottom jaw 6018, as shown in FIG. 13, the
end effector's diameter can be effectively increased over 5 mm such
that the end effector 6004 cannot be fully advanced through the
port 6024.
FIG. 14, FIG. 15, and FIG. 16 illustrate another embodiment of a
mating element that includes a latch configured to removably couple
to an engagement feature. In this illustrated embodiment, the
mating element includes first and second latches 6026a, 6026b, and
the engagement feature includes first and second cut-outs 6028a,
6028b configured to receive the first and second latches 6026a,
6026b, respectively. The first and second latches 6026a, 6026b and
the first and second cut-outs 6028a, 6028b can generally be
configured and used similar to the mating element 6014 and the
engagement feature 6016, respectively, of FIG. 9. In this
illustrated embodiment, a bottom jaw 6030 of an end effector (not
shown) includes the first and second cut-outs 6028a, 6028b and
includes a channel 6032 configured to releasably and replaceably
seat a cartridge 6034 that includes the first and second latches
6026a, 6026b. However, as mentioned above, in other embodiments,
the end effector or other part of a device that includes the end
effector can include the mating element, and the cartridge 6034 can
include the engagement feature.
The first and second latches 6026a, 6026b can be positioned on
opposite lateral sides of the cartridge 6034, and the first and
second cut-outs 6028a, 6028b can be correspondingly positioned on
opposite lateral sides of the bottom jaw 6030, e.g., on opposite
lateral sides of the channel 6032. The mating element and the
engagement feature being located on lateral sides of the cartridge
6034 and bottom jaw 6030 that seats the cartridge 6034 can help
ensure that the cartridge 6034 is not skewed laterally within the
channel 6032.
When the cartridge 6034 is inserted into the channel 6032 in a
proximal direction 6036, as shown in FIG. 15, the first and second
latches 6026a, 6026b can be configured to dynamically move in
response to the insertion, e.g., flex radially inward, as shown in
FIG. 16. Inserting the cartridge 6034 in the proximal direction
6036 allows the cartridge 6034 to be easily seated within the
cartridge 6034 in one motion. When the first and second latches
6026a, 6026b align with the first and second cut-outs 6028a, 6028b,
respectively, the first and second latches 6026a, 6026b can be
configured to snap into the first and second cut-outs 6028a, 6-28b
so as to secure the cartridge 6034 within the bottom jaw 6030. FIG.
15 shows the cartridge 6034 fully seated within the channel 6032 of
the bottom jaw 6030 with the first and second latches 6026a, 6026b
snapped into the first and second cut-outs 6028a, 6028b.
In some embodiments, a surgical device can include at least on
biasing element configured to bias a cartridge out of an end
effector to which the cartridge can be removably coupled. The at
least one biasing element can facilitate removal of the cartridge
from the end effector and/or can be configured to indicate when the
cartridge is not fully seated within the end effector. As in this
illustrated embodiment, the bottom jaw 6030 that seats the
cartridge 6034 can include a biasing element 6038a, 6038b. There
are two biasing elements 6038a, 6038b in this illustrated
embodiment, but a surgical device can include another number of
biasing elements. The at least one biasing element 6038a, 6038b can
have a variety of sizes, shapes, and configurations. As in this
embodiment, the biasing elements 6038a, 6038b can include a coil
spring. In other embodiments, the at least one biasing element
6038a, 6038b can include, e.g., a volute spring, an elastic member
similar to a rubber band, a leaf spring, etc. Each of the biasing
element 6038a, 6038b can be biased in a distal direction 6038, as
shown in FIG. 16.
When the cartridge 6034 is inserted into and seated within the
bottom jaw 6030, the cartridge 6034 can compress the biasing
elements 6038a, 6038b, as shown in FIG. 15. If the cartridge 6034
is not fully seated in the bottom jaw 6030, the bias of the at
least one biasing element 6038a, 6038b can cause the cartridge 6034
to protrude out of the bottom jaw 6030, thereby indicating that the
cartridge 6034 is not fully seated therein. When the cartridge 6034
is removed from the bottom jaw 6030, e.g., by pressing the first
and second mating elements 6026a, 6026b radially inward, the
biasing elements 6038a, 6038b can urge the cartridge 6034 in the
distal direction 6040. This urging can cause the cartridge 6034 to
extend a distance 6042 distally beyond where the cartridge 6034 is
fully seated within the bottom jaw 6030, which can facilitate
grasping of the cartridge 6034 and removal thereof from the bottom
jaw 6030. A secondary tool thus need not be used to remove the
cartridge 6034 from the bottom jaw 6030.
FIG. 17 illustrates an alternate embodiment of a biasing element
6044a, 6044b that can be configured and used similar to the biasing
elements 6038a, 6038b of FIG. 15. The at least one biasing element
6044a, 6044b in this illustrated embodiment also includes a coil
spring. In the embodiment of FIG. 15, the biasing element 6038a,
6038b extend from an inner surface of the bottom jaw 6030 in the
distal direction 6040. In this illustrated embodiment, the biasing
element 6044a, 6044b each extend from an inner surface of a bottom
jaw 6050 that seats a cartridge 6052 in an upward direction 6046
that is substantially perpendicular to a distal direction 6048. The
cartridge 6052 can be configured to be seated in the bottom jaw
6050 by being advanced in a downward direction 6054 into a channel
6056 thereof. The biasing elements 6044a, 6044b can be biased in
the upward direction 6046 such that when the cartridge 6052 is
removed from the bottom jaw 6050, the biasing elements 6044a, 6044b
can urge the cartridge 6052 in the upward direction 6046, thereby
facilitating grasping and removal of the cartridge 6052 from the
bottom jaw 6050.
Instead of a cartridge being removably coupled to an end effector
fixedly attached to an elongate shaft of a surgical device, the end
effector can be removably coupled to the elongate shaft, as will be
appreciated by a person skilled in the art. In other words, the end
effector can be modular. The end effector can include a cartridge
fixed therein, although in some embodiments, the end effector can
be configured to have a cartridge releasably and replaceably seated
therein. Such a surgical device can include one of at least one
mating element and at least one engagement feature, and such a
modular end effector can include the other of the at least one
mating element and the at least one engagement feature. The at
least one mating element and the at least one engagement feature
can generally be configured and used similar to those discussed
above.
FIG. 18 illustrates one embodiment of a surgical device that
includes an elongate shaft 6058 and a modular end effector 6060
configured to removably couple to a distal end of the shaft 6058.
The end effector 6060 in this illustrated embodiment includes a
cartridge 6062 fixedly seated therein. The end effector 6060 can
include at least one mating element 6072 configured to removably
couple to at least one engagement feature 6074 of the shaft 6058.
As in this illustrated embodiment, the at least one mating feature
6072 can include one or more protrusions, and the at least one
engagement feature 6074 can include one or more notches that are
each configured to seat one of the protrusions therein. Similar to
that discussed above, if the at least one mating feature 6072 and
the at least one engagement feature 6074 are only partially
engaged, the end effector 6060 can be prevented from being inserted
into a patient. The end effector 6060 includes two protrusions and
the shaft 6058 includes two notches in this illustrated embodiment,
but there can be a different number of protrusions and
corresponding notches. In another embodiments, the end effector
6060 can include at least one engagement feature, and the shaft
6058 can include at least one mating element.
The shaft 6058 in this illustrated embodiment has a proximal
portion 6064 of a first drive rod movably positioned therein and a
proximal portion 6070 of a second drive rod movably positioned
therein. The first drive rod can be configured to be actuated at a
handle (not shown) of the device to effect opening and closing of
the end effector 6060, e.g., opening and closing of the end
effector's first and second jaws 6066, 6068. The second drive rod
can be configured to be actuated at the handle to effect firing of
fasteners (not shown) from the cartridge 6062. The end effector
6060 in this illustrated embodiment has a distal portion 6076 of
the first drive rod movably positioned therein and has a distal
portion 6078 of the second drive rod movably positioned therein,
When the at least one mating element 6072 is removably coupled to
the at least one engagement feature 6074 so as to removably couple
the end effector 6060 and the shaft 6058, the proximal and distal
portions 6064, 6072 of the first drive rod can be in operative
contact, and the proximal and distal portions 6070, 6078 of the
second drive rod can be in operative contact. A distal end of the
first drive rod's proximal portion 6064 can include at least one
mating element 6080 configured to removably mate with a
corresponding at least one engagement feature 6082 at a proximal
end of the first drive rod's distal portion 6076. Similarly, a
distal end of the second drive rod's proximal portion 6070 can
include at least one mating element 6084 configured to removably
mate with a corresponding at least one engagement feature 6086 at a
proximal end of the second drive rod's distal portion 6078.
Although the proximal portions 6064, 6070 include engagement
features in this illustrated embodiment, in other embodiments, the
proximal portions 6064, 6070 can include engagement features
configured to engage with corresponding mating elements of the
distal portions 6072, 6078.
The end effector 6060 can be biased, e.g., spring biased, to an
open position. The second drive rod can be configured such that
after the fasteners have been fired from the cartridge 6062, e.g.,
by distally advancing the second drive rod through the cartridge
6062 with the end effector 6060 in a closed position, the second
drive rod can be retracted so as to cause the end effector 6060 to
move from the closed position to the open position. Retracting the
end effector 6060 through an access device through which the end
effector 6060 was inserted into a patient's body can be configured
to cause the end effector 6060 to move from the open position to
the closed position so as to allow the end effector 6060 to be
removed from the patient's body, but the biasing of the end
effector 6060 can cause the end effector 6060 to be in the open
position once removed from the access device. The open position can
indicate that the cartridge 6062 should be removed and replaced
before again attempting to fire fasteners from the end effector
6060, thereby providing safety.
A person skilled in the art will appreciate that the present
invention has application in conventional minimally-invasive and
open surgical instrumentation as well application in
robotic-assisted surgery.
The devices disclosed herein can also be designed to be disposed of
after a single use, or they can be designed to be used multiple
times. In either case, however, the device can be reconditioned for
reuse after at least one use. Reconditioning can include any
combination of the steps of disassembly of the device, followed by
cleaning or replacement of particular pieces and subsequent
reassembly. In particular, the device can be disassembled, and any
number of the particular pieces or parts of the device can be
selectively replaced or removed in any combination. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device can utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
* * * * *
References